Chlamydia trachomatis is the etiologic agent in several types of human infection including urethritis, mucopurulent cervicitis in females, and inclusion conjunctivitis and pneumonitis of newborns.
While anti-chlamydial drug therapy exists, many chlamydial infections go untreated because of the limitations connected with current diagnostic methods. This is a significant problem for females where the majority of cervical infections are asymptomatic and, if untreated, may progress to pelvic inflammatory disease which can result in infertility. A commonly used method for detecting chlamydia depends upon culture techniques. This technique is laborious and time-consuming. Thus, a reliable, rapid and inexpensive test to identify the organism is desirable so that proper therapy can be initiated.
Immunoassays such as enzyme and direct fluorescent immunoassays detecting various chlamydial antigens, such as lipopolysaccharide (LPS) and major outer membrane protein (MOMP), are currently used to detect the presence of chlamydia in patient samples. In the case of enzyme immunoassay, samples are commonly pretreated with detergents to solubilize MOMP or LPS antigens for subsequent antibody binding. However, false negative and false positive results from such immunoassays tend to occur in significant numbers. Pretreatment of specimens with detergent does not eliminate the occurence of such false positive and false negative results.